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Recruiting Phase 2 2025-524177-16-00

An open-label, single-center, non-controlled pilot clinical trial to assess the efficacy of weekly semaglutide in combination with regular counselling sessions to reduce craving and use of chemsex associated drugs (CoSem4Chemsex) study.

Phase 2 – studying effectiveness and dosage
Conditions: Craving for and use of chemsex-related drugs

Sponsor: Institute Of Tropical Medicine

trial.available_in: БГ
Overview
Trial status: Authorised Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)
Description
Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide
Who can participate
Age group: 65+ years, 18-64 years Gender: Male Target enrollment: 22 participants
Interventions
Ozempic 0.25 mg solution for injection in pre-filled pen
Drug
Ozempic 0.5 mg solution for injection in pre-filled pen
Drug
Ozempic 1 mg solution for injection in pre-filled pen
Drug
Locations 1
Belgium (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
12.02.2026
Registry ID
2025-524177-16-00
Source
euclinicaltrials.eu
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